Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

Phase 4

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: Teriparatide 40-mcg subcutaneous injection; Drug: Denosumab Injection; Drug: Alendronate Oral Tablet

• Registration Number: NCT01750086
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-26
• Study First Submitted QC: 2012-12-13
• Study First Posted: 2012-12-17
• Study Start: 2013-01
• Primary Completion: 2014-04
• Study Completion: 2014-08
• Results First Submitted: 2016-11-30
• Results First Submitted QC: 2016-11-30
• Results First Posted: 2016-12-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

Inclusion Criteria

Must satisfy A and B and C below:

A. Women aged 45+

B. Postmenopausal

C. Osteoporotic with high risk of fracture

Exclusion Criteria

• History of significant hepatic, renal, cardiovascular, malignant disease, or conditions with impaired immune system
• Current alcohol or substance abuse
• Major psychiatric disorders
• Abnormal calcium level, elevated PTH, vitamin D deficiency, or anemia
• Known congenital or acquired bone disease other than osteoporosis
• Current use or past use in the past 12 months of oral bisphosphonates
• Current use or use in the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin
• Use of oral or parenteral glucocorticoids for more than 14 days in the past 6 months
• Any current or previous use of strontium or intravenous bisphosphonates
• Sensitivity to cell-derived drug products or teriparatide
• Extensive dental work involving dental extraction or dental implant within the past 2 months or in the upcoming 2 months
• Inability to sit upright for 30 minutes
• Esophageal abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Denosumab 60mg subcutaneous injection	Teriparatide 40-mcg subcutaneous injection	Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Denosumab 60mg subcutaneous injection	Denosumab Injection	Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Alendronate 70mg weekly x 8 weeks	Teriparatide 40-mcg subcutaneous injection	Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Alendronate 70mg weekly x 8 weeks	Alendronate Oral Tablet	Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.

Primary Outcome Measures

Name	Time	Method
Bone Turnover Marker (Blood Sample)	8 weeks	The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States